Complaints

This page outlines complaints processes.

Page last updated: 05 February 2015

If you have any concerns or complaints about the ethical review process or the ethical aspects of a research project that has been considered by the Committee, please advise the Department of Health Human Research Ethics Committee ('the Committee') Secretariat in the first instance. The complaint will then be referred to the Chair of the Committee for review.

Technical or administrative questions including how to respond to requests from researchers and how to withdraw from a research project should be directed to the researchers.

The complaints processes are outlined below.

Complaints about the conduct of a project that has been granted ethical approval

A person, whether he/she is a project participant, researcher or other interested person, with a complaint about the conduct of a project, should bring the complaint to the attention of the Committee Secretariat, detailing the grounds of the complaint. The complaint should be made in writing to the Committee Secretariat and will then be referred to the Chair of the Committee for review.

The Chair will investigate the complaint and the Principal/Senior Researcher of the project will be notified of the complaint by the Committee Secretariat. Further information from relevant persons may be sought during the investigation of the complaint. In some cases, the Principal/Senior Researcher may be required to attend a Committee meeting to discuss the complaint. The Committee will respond urgently where there is any suggestion of harm to participants, researchers or any other persons.

The Chair, having considered the matter on behalf of the Committee, will make a recommendation on the appropriate course of action.

The Committee will inform the Principal/Senior Researcher of the result and any action arising from the investigation of the complaint. These actions may include:

a caution;

increased monitoring by the Committee;

the requirement for amendments to the project;

suspension of ethical approval; or

termination of ethical approval.

The complainant will be advised in writing of the outcome of the investigation.

If the complainant is not satisfied with the outcome of the preliminary investigation, then he/she can refer the complaint to the Assistant Secretary of the Information Knowledge Management Branch who will consider an appropriate course of action.

At the Committee’s discretion, anonymous complaints received will follow the same process.

All complaints received and the course of action taken will be reported to the Secretary of the Department.

Complaints about the ethical review process

A person, whether he/she is a project participant, researcher or other interested person, with a complaint about the ethical review process, should bring the complaint to the attention of the Committee Secretariat, detailing the grounds of the complaint. The complaint should be made in writing to the Committee Secretariat and will then be referred to the Chair of the Committee for review.

The Chair will investigate the complaint and its validity, and make a recommendation on behalf of the Committee on the appropriate course of action. The complainant will be advised in writing of the outcome of the investigation.

If the complainant is not satisfied with the outcome of the preliminary investigation, then he/she can refer the complaint to the Assistant Secretary of the Information Knowledge Management Branch who will consider an appropriate course of action.

Complaints of bias or impropriety on the part of a Committee member or members can be made directly to the Assistant Secretary of the Information Knowledge Management Branch.

The Committee will only consider review of an ethical decision where a complaint about its ethical review process is substantiated. The Committee will not conduct a review merely because a researcher is dissatisfied with the merits of an ethical decision itself.

All complaints received and the course of action taken will be reported to the Secretary of the Department.